Phase 2 TAK-831
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia
IRAS ID
228435
Contact name
James Stone
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2017-001739-38
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Summary of Research
Schizophrenia is a chronic, debilitating psychiatric disorder that affects up to 1 percent of people throughout the world and places a substantial burden on patients, their families, and society. Symptoms can include social withdrawal, decreased motivation, impaired ability to communicate and cognitive impairment (e.g. difficulty remembering, learning new things, concentrating or making decisions). Antipsychotics are effective in treating the positive symptoms of schizophrenia (e.g., delusions and hallucinations) but are less effective in treating negative symptoms (e.g. cognitive impairment).
TAK-831 blocks an enzyme called D-amino acid oxidase (DAO) which leads to an increase in the level of an amino acid in parts of the brain when tested in animal models. These increased brain levels are expected to enhance certain mechanisms that may contribute to the negative symptoms of schizophrenia.
The study medication, TAK-831, is expected to act on the negative and cognitive symptoms of schizophrenia. A medication that safely and effectively treats these symptoms would be an important addition to treatment options available for these patients.
This study is a randomised, double-blind, placebo-controlled, two-period crossover study to evaluate the, pharmacodynamics (how the medication affects the body), safety, tolerability and pharmacokinetics (how the medication moves in the body) of multiple oral doses of TAK-831 in adult patients with schizophrenia.
The study will be conducted at a single centre. Approximately 32 adult participants aged 18 to 55, with a diagnosis of schizophrenia currently on a stable dose of antipsychotic medication will be included. Participants will be randomly assigned to one of two treatment sequences, each receiving one period of treatment with TAK-831 and one with placebo (a dummy drug with no active medication in it). Each will be given for a period of eight days, separated by 10-21 day period. Participants must continue to take their current antipsychotic medication during the study.Summary of Results
Not currently available.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0196
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion